BioGlue Surgical Sealant Electronic Instructions for Use (eIFU)

eIFU: BioGlue Syringe (L6312)

Product Codes: BG3502-5-US, BG3510-5-US, BG3515-5-US
Region: USA
FDA approved: Yes
CE Marked: No
Languages: English

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eIFU: BioGlue Syringe (L09330)

Product Codes: BG3502-5-G, BG3510-5-G, BG3515-5-G
Region: Global, excluding USA
FDA approved: No
CE Marked: Yes, CE0124
Languages: Brazilian Portuguese(pt-br), Bulgarian(bg), Croatian(hr), Czech(cs), Danish(da), Dutch(nl), English(en), Estonian(et), Finnish(fi), French(fr), German(de), Greek(el), Hungarian(hu), Italian(it), Latvian(lv) Lithuanian(lt), Polish(pl), Portuguese(pt), Romanian(ro), Russian(ru), Slovak(sk), Slovenian(sl), Spanish(es), Swedish(sv), Turkish(tr)

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eIFU: BioGlue DTE (L09332)

Product Codes: BGDTE-10, BGDTE-27, BGDTE-35
Region: Global
FDA approved: Yes
CE Marked: Yes, CE0124
Languages: Brazilian Portuguese(pt-br), Bulgarian(bg), Croatian(hr), Czech(cs), Danish(da), Dutch(nl), English(en), Estonian(et), Finnish(fi), French(fr), German(de), Greek(el), Hungarian(hu), Italian(it), Latvian(lv) Lithuanian(lt), Polish(pl), Portuguese(pt), Romanian(ro), Russian(ru), Slovak(sk), Slovenian(sl), Spanish(es), Swedish(sv), Turkish(tr)

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eIFU: BioGlue Accessories (L09280)

Product Codes: BGAT-SY, BGAT-10-SY BGAT-27-SY, BGST-12, BGST-16
Region: Global
FDA approved: Yes
CE Marked: Yes, CE0124
Languages: Brazilian Portuguese(pt-br), Bulgarian(bg), Croatian(hr), Czech(cs), Danish(da), Dutch(nl), English(en), Estonian(et), Finnish(fi), French(fr), German(de), Greek(el), Hungarian(hu), Italian(it), Latvian(lv) Lithuanian(lt), Polish(pl), Portuguese(pt), Romanian(ro), Russian(ru), Slovak(sk), Slovenian(sl), Spanish(es), Swedish(sv), Turkish(tr)

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